Data / Medical devices / United States / Fziomed, Inc.
Fziomed, Inc.: FDA-registered device maker in San Luis Obispo, CA, United States, 2 510(k) clearances
Fziomed, Inc. is registered with the FDA (registration 2031637) in San Luis Obispo, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031637
- FEI number
- 3004474407
- Address
- 231 Bonetti DR, San Luis Obispo, CA, United States, 93401
- Owner or operator
- FZIOMED, INC. (9034681)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- February 17, 2009
- Registered through
- 2026
- Brand names listed
- DYNAVISC, Intercoat AP, Intercoat IU, Interpose, MediShield, MediShield 1mL, Oxiplex, Oxiplex 1mL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Gel For Intraoperative Use In Spine Surgery | QVL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Barrier, Absorbable, Adhesion | MCN | 3 | Manufacturer for export | accessdata.fda.gov |
| Inhibitor, Peridural Fibrosis (Adhesion Barrier) | MLQ | 3 | Manufacturer for export | accessdata.fda.gov |
| Inhibitor, Postoperative Fibrosis (Adhesion Barrier) | OZJ | N | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2026 | K253326 | Oxiplex | QVL | Substantially Equivalent | Fziomed, Inc. | accessdata.fda.gov |
| June 17, 2025 | DEN240038 | Oxiplex® | QVL | Unknown | Fziomed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.